PharMEDium Recalls Fentanyl and Bupivacaine Bags Due to Glass Particulates
PharMEDium Services is recalling 105 bags of compounded Fentanyl Citrate and Bupivacaine HCl sterile injectable drugs due to the presence of glass particulate matter.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this as an FDA Class II recall involving a sterile injectable drug contaminated with glass particulates, which poses a significant risk of injury.
Plain-English summary
PharMEDium Services, LLC is recalling 105 bags of 2.5 mcg/mL Fentanyl Citrate and 0.0312% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride. The product is a sterile injectable drug compounded in 250 mL Hospira LifeCare Bags. The recall was initiated because the active pharmaceutical ingredient (API) used to produce the drugs was contaminated with glass particulate matter.
The affected product is identified by NDC 61553-195-50 and Service Code 2H9195. The recall covers specific lots with expiration dates ranging from May 8, 2016, to June 30, 2016. The product was distributed nationwide.
Healthcare providers and patients should stop using the affected product immediately. The FDA classifies this as a Class II recall, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- 2.5 mcg/mL Fentanyl Citrate and 0.0312% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Hospira LifeCare Bag, Service Code 2H9195, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-195-50
- Manufacturer
- Pharmedium Services, LLC
- Category
- Drug — Sterile Injectable
- Affected units
- 105
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Lot Number 160890247M
- Exp. Date 6/28/2016
- Lot Number 160380151M
- Exp. Date 5/8/2016
- Lot Number 160490238M
- Exp. Date 5/19/2016
- Lot Number 160550208M
- Exp. Date 5/25/2016
- Lot Number 160610062M
- Exp. Date 5/30/2016
- Lot Number 160630184M
- Exp. Date 6/2/2016
- Lot Number 160700191M
- Exp. Date 6/9/2016
- Lot Number 160750045M
- Exp. Date 6/13/2016
- Lot Number 160770156M
- Exp. Date 6/16/2016
- Lot Number 160910163M
- Exp. Date 6/30/2016
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 75 recalled by Pharmedium Services, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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